ID
38671
Description
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis
Keywords
Versions (2)
- 1/11/19 1/11/19 -
- 10/30/19 10/30/19 - Sarah Riepenhausen
Copyright Holder
GSK group of companies
Uploaded on
October 30, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056
Miscellaneous Forms: Temperature Log, Adverse Events, Rash, Gland Swelling, Febrile Convulsions, Concomitant Medication
Description
Temperature Log
Description
Please record all temperatures within 15 days post-vaccination; Definistion of Fever: Axillary (preferrably ) ≥ 37.5 °C, Rectal ≥ 38°C
Data type
integer
Description
temperature taken?
Data type
text
Description
Day of Fever event
Data type
text
Description
Type of measurementBodyTemperature
Data type
text
Description
Temperature
Data type
float
Measurement units
- °C
Description
If fever
Data type
boolean
Description
medically attended visit
Data type
boolean
Description
medical involvement
Data type
text
Description
Reminder
Description
Rash / Exanthem
Description
Rash Event Log
Description
Rash Episode Number
Data type
integer
Description
Description
Data type
text
Description
Administration Site
Data type
text
Description
AdministrationSiteVaccine
Data type
text
Description
If non-administration site, please record the site
Data type
text
Description
Date started
Data type
date
Description
Date stopped
Data type
date
Description
Rash intensity
Data type
text
Description
Relationship to investigational product
Data type
boolean
Description
Outcome
Data type
text
Description
medicallyAttendedVisit
Data type
boolean
Description
TypeMedicalAttendance
Data type
text
Description
Parotid/Salivary Gland Swelling Events
Description
Episode Number
Data type
integer
Description
Description
Data type
text
Description
Date started
Data type
date
Description
Date stopped
Data type
date
Description
Intensity
Data type
integer
Description
Saliva sample
Data type
boolean
Description
Date sample taken
Data type
date
Description
Causality
Data type
boolean
Description
Outcome
Data type
integer
Description
MedicallyAttendedVisit
Data type
boolean
Description
MedAttendanceType
Data type
text
Description
Febrile Convulsions - Suspected Signs of Meningitis
Description
Episode Number
Data type
integer
Description
Description
Data type
text
Description
Date started
Data type
date
Description
Date stopped
Data type
date
Description
Intensity
Data type
integer
Description
NeurologicalExamination
Data type
boolean
Description
LumbarPuncturePerformed?
Data type
boolean
Description
MedRepostofLumbarPuncure
Data type
text
Description
Causality
Data type
boolean
Description
Outcome
Data type
text
Description
MedicallyAttendedVisit
Data type
boolean
Description
MedAttendanceType
Data type
text
Description
Concomitant Vaccination
Description
Concomitant Vaccination Details
Description
Trade/Generic Name
Data type
text
Description
Route
Data type
integer
Description
Administration Date
Data type
date
Description
Concomitant Medications
Description
Concomitant Medications Details
Description
Trade/Genereic Name
Data type
text
Description
ProphylacticAdministration
Data type
boolean
Description
Medical Indication
Data type
text
Description
Total daily dose
Data type
text
Description
Route
Data type
integer
Description
If Other, please specify
Data type
text
Description
Start Date
Data type
date
Description
End Date
Data type
date
Description
Ongoing?
Data type
boolean
Description
Non-Serious Adverse Events
Description
Non-Serious Adverse Events Log
Description
Episode Number
Data type
integer
Description
Description
Data type
text
Description
AdministrationSite
Data type
text
Description
vaccine
Data type
text
Description
Date started
Data type
date
Description
Date stopped
Data type
date
Description
Intensity
Data type
text
Description
RelationshipToInvestigationalProducts
Data type
boolean
Description
Outcome
Data type
text
Description
Medically attended visit
Data type
boolean
Description
MedAttendanceType
Data type
text